Phase I Study of Hemay102 in Patients With Advanced Solid Tumors

NCT03982303 | Unknown Phase 1

• 1 other identifier: HM102ST1S01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This trial was a single-center, open-label, dose-increasing Phase I clinical study with subjects enrolled in patients with advanced solid tumors who failed standard treatment or who were unable to receive effective treatment. The trial is divided into two stages: dose escalation and dose extension.

Conditions

Patients With Advanced Stage Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  Number of participants with adverse events

  from baseline until 4 weeks after the study day

Secondary Outcomes (4)

• Objective response rate

  At screening, every 6 weeks of treatment up to 18 months

• Clinical benefit rate

  At screening, every 6 weeks of treatment up to 18 months

• Progression Free Survival

  18 months after treatment initiation

• AUC

  0, 1, 2, 3, 5, 8, 12, 24, 48 and 72 hours post-dose

Study Arms (7)

Hemay102 at the dosage of 5mg/m2

EXPERIMENTAL

Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 5mg/m2.

Drug: Hemay102

Hemay102 at the dosage of 10mg/m2

EXPERIMENTAL

Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 10mg/m2.

Drug: Hemay102

Hemay102 at the dosage of 20mg/m2

EXPERIMENTAL

Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 20mg/m2.

Drug: Hemay102

Hemay102 at the dosage of 40mg/m2

EXPERIMENTAL

Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 40mg/m2.

Drug: Hemay102

Hemay102 at the dosage of 60mg/m2

EXPERIMENTAL

Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 60mg/m2.

Drug: Hemay102

Hemay102 at the dosage of 90mg/m2

EXPERIMENTAL

Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 90mg/m2.

Drug: Hemay102

Hemay102 at the dosage of 120mg/m2

EXPERIMENTAL

Hemay102 will be administered to patients through i.v. drip for 4hrs at the dosage of 120mg/m2.

Drug: Hemay102

Interventions

Hemay102 DRUG

Hemay102 was administered through i.v. infusion for 4hrs.

Hemay102 at the dosage of 10mg/m2; Hemay102 at the dosage of 120mg/m2; Hemay102 at the dosage of 20mg/m2; Hemay102 at the dosage of 40mg/m2; Hemay102 at the dosage of 5mg/m2; Hemay102 at the dosage of 60mg/m2; Hemay102 at the dosage of 90mg/m2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old and ≤70 years old, male or female;
• A patient who has been confirmed by histology or cytology to have advanced or metastatic solid tumors (in the patients with locally advanced hepatocellular carcinoma or metastatic liver cancer, patients can be recruited by clinical diagnosis) and who have failed standard treatment or who are unable to receive/do not have effective treatment;
• At least one evaluable tumor lesion (spiral CT scan with a long diameter ≥ 10 mm, in accordance with RECIST version 1.1);
• ECOG PS score 0\~1 within 1 week before enrollment;
• Estimated survival time of more than 3 months;
• Appropriate hematopoietic function: white blood cell count ≥ 3 × 10\^9 / L; absolute neutrophil count ≥ 1.5 × 10\^9 / L; platelet count ≥ 100 × 10\^9 / L; hemoglobin ≥ 90 g / L;
• Appropriate liver function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate transferase (AST) ≤ 2.5 × ULN; alanine aminotransferase (ALT) ≤ 2.5 × ULN;
• Proper renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL / min according to the Cockcroft-Gault formula;
• For clinically confirmed unresectable locally advanced hepatocellular carcinoma or metastatic liver cancer, the patient's liver function must meet the criteria below: ALT≤2.5×ULN, AST≤2.5×ULN, TBIL≤1.5×ULN, Child-Pugh score A or B Grade (≤7 points), blood ammonia ≤100μmol/L (only for patients with hepatocellular carcinoma);
• A qualified male or female patient with fertility must agree to use a reliable method of contraception (hormone or barrier method) after signing the informed consent until at least 12 weeks after the last dose;
• Subjects must give informed consent to the study prior to the trial and voluntarily sign a written informed consent form;
• Subjects are able to communicate well with the investigator and are able to complete the study in accordance with the trial regulations.

You may not qualify if:

• Subjects known to have or suspected to have brain metastases;
• Have received radiation therapy within 4 weeks before enrollment;
• Drugs that may affect the metabolism of this product, such as CYP3A4 strong inducer (rifampicin, carbamazepine, phenytoin, etc.) or strong inhibitors (clarithromycin, protease, triazole antifungals, etc.), should be combined within 2 weeks before the study or during the study period;
• Patients who have previously received anthracycline treatment; or who are known to have a history of allergies to anthracyclines (eg, doxorubicin, epirubicin);
• Have active infection or HIV-positive infection or other serious illness;
• Uncontrolled or important cardiovascular disease, which included a) New York Heart Association (NYHA) grade II or higher congestive heart failure, unstable angina, myocardial infarction, or arrhythmia requiring treatment (including atrial fibrillation, at screening) within 6 months prior to the first study drug administration Supraventricular tachycardia, ventricular tachycardia or ventricular fibrillation, or left ventricular ejection fraction (LVEF) \< 50%; b) Primary cardiomyopathy (eg dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, undetermined cardiomyopathy); c) Clinically significant QTc interval prolongation history, or screening period QTc interval (corrected by Bazette) ≥ 450ms (male) or ≥ 470ms (female); d) Coronary heart disease with symptoms requiring medication; e) Uncontrollable hypertension (refers to post-treatment systolic blood pressure \> 160 mmHg and / or diastolic blood pressure \> 100 mmHg);
• A history of hemorrhagic or thromboembolic events in the past 6 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, and spontaneous bleeding of the tumor;
• Medical treatment for other clinical trials within 4 weeks prior to enrollment;
• \<4 weeks after major surgery or trauma after enrollment;
• Must take other treatments during the trial, such as other chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy (except for local symptomatic radiotherapy) or Chinese medicine;
• Concomitant mental illness;
• The investigator believes that the subject is not suitable for this clinical study.

Sponsors & Collaborators

• Tianjin Hemay Oncology Pharmaceutical Co., Ltd: lead

Study Sites (1)

Tianjin medical university cancer hoapital

Tianjin, China

RECRUITING

Study Officials

• Ti Zhang, Ph.D.

  Tianjing medical university cancer hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueying Zhen, Ph.D.

CONTACT

86-22-2492-9366; zhenyueying@hemay.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: open-label
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2019
• First Posted: June 11, 2019
• Study Start: January 3, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

CN (1)